CN115282240A - 治疗白癜风的中药组合物及制法、包含其的制剂及应用 - Google Patents
治疗白癜风的中药组合物及制法、包含其的制剂及应用 Download PDFInfo
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- CN115282240A CN115282240A CN202211005513.2A CN202211005513A CN115282240A CN 115282240 A CN115282240 A CN 115282240A CN 202211005513 A CN202211005513 A CN 202211005513A CN 115282240 A CN115282240 A CN 115282240A
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Abstract
本发明涉及一种治疗白癜风的中药组合物及制法、包含其的制剂及应用,所述治疗白癜风的中药组合物,包括以下原料药:柴胡、黄芩、法半夏、桂枝、防风、炒白术、黄柏、薏苡仁、牛膝、知母、百合、金钱草、络石藤、白芷、当归、桃仁、黄精、杜仲、阿胶。本发明所述治疗白癜风的中药组合物,合而成为沟通表里、温经通络、和解清热、补肾滋阴之剂,使得白癜风患者少阳枢机得利、气化以行、通经活络、气血调和。临床应用显示,本发明能够更有效地缩小白癜风患者皮损面积、改善皮损状况,更好地维持外周血VECF及Th17/Trer细胞平衡,提高患者生活质量,并且用药安全性高,值得推广应用。
Description
技术领域
本发明属于中药技术领域,具体涉及一种治疗白癜风的中药组合物及制法、包含其的制剂及应用。
背景技术
白癜风是一种比较常见的后天色素性皮肤病,表现为局限性或泛发性皮肤黏膜色素完全脱失。全身各部位可发生,常见于指背、腕、前臂、颜面、颈项及生殖器周围等。女性外阴部亦可发生,青年妇女居多。性别无明显差异,各年龄组均可发病,但以青少年好发。皮损为色素脱失斑,常为乳白色,也可为浅粉色,表面光滑无皮疹。白斑境界清楚,边缘色素较正常皮肤增加,白斑内毛发正常或变白。病变好发于受阳光照射及磨擦损伤部位,病损多对称分布。白斑还常按神经节段分布而呈带状排列。除皮肤损害外,口唇、阴唇、龟头及包皮内侧黏膜也常受累。本病多无自觉症状,少数患者在发病前或同时有患处局部瘙痒感。白癜风常伴其他自身免疫性疾病,如糖尿病、甲状腺疾病、肾上腺功能不全、硬皮病、异位性皮炎、斑秃等。
白癜风的发病机制极其复杂,可能与自身免疫、遗传、炎症反应、神经介导、黑色素细胞自毁等因素相关。目前临床上治疗白癜风的方法有内服药物、外用药物、光疗、自体表皮移植等,其中,308nm紫外线治疗是近年来采用光疗手段治疗白癜风的首选方案,308nm波长的紫外线可直接诱导皮损中T细胞的凋亡,促进黑素细胞的快速增殖及迁移,减轻皮损部位氧化应激反应,从而加快皮损白斑的修复。然而相关研究表明,308nm紫外照射只对皮损面积小于30%的局限性白癜风疗效显著,而对于皮损面积较大的白癜风治疗效果有限。
随着对白癜风诊疗方法的深入研究,越来越多的国内外学者提倡联合多种治疗手段用于白癜风治疗效果更优,这为白癜风的临床治疗提供了更多选择,其中,联合中药治疗成为近来研究的热门。中医书籍中早有关于白癜风的记载,如《诸病源候论》谓“面及颈项身,皮肉色变白而肉色不同,也不痒痛,谓之白癜”;《疡科大全》记载“白癜……起于手足者居多”。而关于白癜风的病机,中医认为在于风邪侵于肌肤而气血不足、气滞血瘀。《诸病源候论》记载“风邪搏於肌肤,气血不和而成”;《文堂集验方》指出“脾滞而生”。故中医治疗白癜风的原则以祛风散热、活血化瘀、调和气血为主,但纵观现有的治疗白癜风的中药疗效并不显著,迫切需要新的更有效的中药出现,成为亟待解决的技术问题。
发明内容
本发明的目的在于针对现有技术中存在的上述技术问题,提供一种疗效显著的治疗白癜风的中药组合物及制法、包含其的制剂及应用。
为实现本发明的上述目的,本发明采用以下技术方案:
本发明提供一种治疗白癜风的中药组合物,包括以下重量份的原料药:柴胡3-8重量份、黄芩3-8重量份、法半夏5-15重量份、桂枝5-15重量份、防风5-15重量份、炒白术5-15重量份、黄柏3-8重量份、薏苡仁3-8重量份、牛膝5-15重量份、知母5-15重量份、百合5-15重量份、金钱草5-50重量份、络石藤5-50重量份、白芷5-15重量份、当归5-15重量份、桃仁3-8重量份、黄精5-15重量份、杜仲5-15重量份、阿胶5-15重量份。
优选的,柴胡5重量份、黄芩5重量份、法半夏10重量份、桂枝10重量份、防风10重量份、炒白术10重量份、黄柏5重量份、薏苡仁5重量份、牛膝10重量份、知母10重量份、百合10重量份、金钱草10重量份、络石藤10重量份、白芷10重量份、当归10重量份、桃仁5重量份、黄精10重量份、杜仲10重量份、阿胶10重量份。
本发明提供的治疗白癜风的中药组合物,采用柴胡桂枝汤为基本方加减而成,其中,柴胡、黄芩和解少阳,疏肝理气;法半夏健脾和胃;桂枝温经通络;防风祛风解表;炒白术、黄柏、薏苡仁、牛膝、知母、百合清热利湿;金钱草、络石藤清热解毒;白芷、当归、桃仁养血活血;黄精、杜仲、阿胶补肾滋阴;合而成为沟通表里、温经通络、和解清热、补肾滋阴之剂,使得白癜风患者少阳枢机得利、气化以行、通经活络、气血调和。本发明提供的治疗白癜风的中药组合物,采用中医药整体调理观念,能够改善血液循环,有利于局部色素的形成和代谢,可促进人体淋巴细胞的转化功能,激活络氨酸酶活性,促进黑色素合成,进而逐渐控制病情,达到白斑区病变恢复的治疗效果。
本发明所述治疗白癜风的中药组合物的制备方法,包括如下步骤:取各重量份的原料药,加溶媒提取,经过滤、浓缩、干燥后,即得。所述溶媒优选水或乙醇水溶液。所述提取优选为煎煮提取、回流提取、浸渍提取、超声提取中的任意一种。优选的,取各重量份的原料药,加水煎煮提取2次,每次提取的料液比为1:8-12,每次提取的时间为20-30min,经过滤、滤液合并、浓缩、干燥后,即得。
本发明所述治疗白癜风的中药组合物的基础上,通过加入药学上可接受的辅料,按照常规药物制剂工艺,可制成多种形式的治疗白癜风的中药制剂,包括但不限于汤剂、散剂、丸剂、胶囊剂、颗粒剂、片剂和口服液。
本发明还涉及所述治疗白癜风的中药组合物或治疗白癜风的中药制剂在制备治疗白癜风的药物中的应用。
本发明的有益效果为:
本发明所述治疗白癜风的中药组合物,通过将包括柴胡、黄芩、法半夏、桂枝、防风、炒白术、黄柏、薏苡仁、牛膝、知母、百合、金钱草、络石藤、白芷、当归、桃仁、黄精、杜仲、阿胶在内的共19味原料药组合使用并进行适合的重量配比,使得各原料药相辅相成,合而成为沟通表里、温经通络、和解清热、补肾滋阴之剂,使得白癜风患者少阳枢机得利、气化以行、通经活络、气血调和。临床应用显示,本发明能够更有效地缩小白癜风患者皮损面积、改善皮损状况,更好地维持外周血VECF及Th17/Trer细胞平衡,提高患者生活质量,并且用药安全性高,值得推广应用。
具体实施方式
为使本发明的目的、技术方案和优点更加清楚,下面将对本发明的技术方案进行详细的描述。显然,所描述的实施例仅仅是本发明的一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动的前提下所得到的所有其它实施方式,都属于本发明所保护的范围。
实施例1
一种治疗白癜风的中药颗粒剂,由以下原料药制成:
柴胡5g、黄芩5g、法半夏10g、桂枝10g、防风10g、炒白术10g、黄柏5g、薏苡仁5g、牛膝10g、知母10g、百合10g、金钱草10g、络石藤10g、白芷10g、当归10g、桃仁5g、黄精10g、杜仲10g、阿胶10g;
制备方法:取各质量配比的原料药,加水煎煮提取2次,先后2次提取的料液比分别为1:12、1:8,每次提取的时间为30min,经过滤、滤液合并、浓缩至生药含量为0.8g/mL、干燥后加入适量糊精,混匀后,经湿法制粒、干燥、整粒、装成15g/袋,即为所述治疗白癜风的中药颗粒剂。
实施例2
一种治疗白癜风的中药颗粒剂,由以下原料药制成:
柴胡3g、黄芩8g、法半夏5g、桂枝15g、防风5g、炒白术15g、黄柏3g、薏苡仁8g、牛膝5g、知母15g、百合5g、金钱草50g、络石藤5g、白芷15g、当归5g、桃仁8g、黄精5g、杜仲15g、阿胶5g;
制备方法:取各质量配比的原料药,加水煎煮提取2次,先后2次提取的料液比分别为1:10、1:8,每次提取的时间为20min,经过滤、滤液合并、浓缩至生药含量为0.8g/mL、干燥后加入适量糊精,混匀后,经湿法制粒、干燥、整粒、装成15g/袋,即为所述治疗白癜风的中药颗粒剂。
实施例3
一种治疗白癜风的中药颗粒剂,由以下原料药制成:
柴胡8g、黄芩3g、法半夏15g、桂枝5g、防风15g、炒白术5g、黄柏8g、薏苡仁3g、牛膝15g、知母5g、百合15g、金钱草5g、络石藤50g、白芷5g、当归15g、桃仁3g、黄精15g、杜仲5g、阿胶15g;
制备方法:取各质量配比的原料药,加水煎煮提取2次,先后2次提取的料液比分别为1:10、1:8,每次提取的时间为25min,经过滤、滤液合并、浓缩至生药含量为0.8g/mL、干燥后加入适量糊精,混匀后,经湿法制粒、干燥、整粒、装成15g/袋,即为所述治疗白癜风的中药颗粒剂。
实施例4
一种治疗白癜风的中药胶囊剂,由以下原料药制成:
柴胡6g、黄芩6g、法半夏12g、桂枝12g、防风12g、炒白术12g、黄柏6g、薏苡仁6g、牛膝12g、知母12g、百合12g、金钱草12g、络石藤12g、白芷12g、当归12g、桃仁6g、黄精12g、杜仲12g、阿胶12g;
制备方法:取各质量配比的原料药,加入体积分数为90%的乙醇水溶液回流提取2次,每次提取的料液比为1:10,每次提取的时间为60min,经过滤、滤液合并、浓缩至生药含量为0.8g/mL、干燥后、粉碎成细粉,装入胶囊,制成0.5g/粒的治疗白癜风的中药胶囊剂。
实施例5
一种治疗白癜风的中药片剂,由以下原料药制成:
柴胡4g、黄芩4g、法半夏8g、桂枝8g、防风8g、炒白术8g、黄柏4g、薏苡仁4g、牛膝8g、知母8g、百合8g、金钱草8g、络石藤8g、白芷8g、当归8g、桃仁4g、黄精8g、杜仲8g、阿胶8g;
制备方法:取各质量配比的原料药,加入体积分数为90%的乙醇水溶液回流提取2次,每次提取的料液比为1:10,每次提取的时间为60min,经过滤、滤液合并、浓缩至生药含量为0.8g/mL、干燥后、粉碎成细粉,加入适量羧甲基淀粉钠、硬脂酸镁,混匀后,经湿法制粒、干燥、整粒、压片,制成0.5g/片的治疗白癜风的中药片剂。
临床试验研究资料
1资料与方法
1.1一般资料
选取2021年6月~12月我院诊治的白癜风患者120例作为研究对象,纳入标准:①成年患者,性别不限;②均符合中华医学会皮肤性病学分会银屑病专业委员会制定的相关疾病标准;③认知、交流能力正常;④知情同意研究内容并且积极配合研究进行。剔除标准:①精神或神经系统疾病患者;②近3月内免疫抑制剂、糖皮质激素类药物应用史;③近1目内外用药物应用史;④严重心肝肾功能或造血系统等器质性疾病患者;奸娠及哺乳期患者。剔除标准:①对研究中治疗药物过敏或治疗方法不耐受的患者;②治疗依从性差,未能完成治疗或数据资料收集的患者。本研究内容符合医学伦理学要求,所有患者按照随机数字表法均分为两组。对照组60例中:男33例,女27例;年龄24~62岁,平均(38.9±4.5)岁;病程1~12年,平均(5.1±1.4)年;皮损部位:头部8例、上肢12例、躯干19例、下肢16例、全身泛发5例。观察组60例中:男31例,女29例;年龄22~63岁,平均(39.1±4.0)岁;病程1~14年,平均(5.3±1.0)年;皮损部位:头部9例、上肢12例、躯干18例、下肢15例、全身泛发6例。两组患者一般资料间差异均无统计学意义(P>0.05)具有可比性。
1.2方法
两组所有患者均采用中药热敷联合308nm LED光源照射治疗。同时对照组给予白驳丸(长春海外制药集团有限公司,国药准字Z22021172)治疗,口服,一次4粒,一日3次。观察组给予本发明实施例1药物治疗,开水冲服,一次15g,一日3次。两组均4周为一疗程,用药2个疗程后观察治疗效果。
1.3观察项目及判定标准
(1)皮损面积:采用皮损面积及严重程度指数(Psoriasis area andseverityindex,PASI)81评估,1个掌面面积相当于全身的1%头部的10%、上肢的5%、躯干的3.3%、下肢的2.5%,头部、上肢、躯干、下肢4个躯体部位分别以0到6分对应无皮疹、1%~9%、10%~29%、30%~49%、50%~69%、70%~89%、90%~100%;红斑、浸润、表皮脱屑/鳞屑分别以0到4分依次对应无、轻微、中等、明显、严重症状,PASI总分为各个躯体部位PASI分值之和。(2)临床疗效:依据《中药新药临床研究指导原则》中相关标准评估,皮损消退,或仅遗留少许色素沉着,症状消失,化验指标正常,积分值减少≥95%为痊前;皮损大部分消退,症状明显减轻,或化验指标接近正常,积分值减少≥70%为显效;皮损部分消退,症状改善,积分值减少≥50%为有效;皮损消退不明显,或临床症状反见恶化,积分值减少不足50%为无效;痊煎、显效、有效合计为总有效。(3)外周血VEGF及Th17/Treg水平,均采集患者外周外周静脉血作为标本,双抗体夹心酶联免疫吸附法测定VEGF,流式细胞仪检测Th17、Treg。(4)生活质量,采用皮肤病生活质量指数(Dermatologylifequalityindex,DLQI)评分,共有症状感受、日常活动、娱乐活动、工作学习、个人活动和治疗等10个问题,每个问题根据无、很少、很大、非常严重分别对应0、1、2、3分,总分30分,分值越低表明生活质量越高。(5)不良反应情况,包括恶心、胃部不适、腹泻、食欲亢进等。
1.4统计学处理
2结果
2.1两组PASI评分比较
治疗前观察组、对照组PASI评分差异无统计学意义(P>005),治疗8周后两组PASI评分显著降低,观察组显著低于对照组,组间差异有统计学意义(P<0.05)。见表1。
2.2两组临床药效比较
观察组、对照组总有效率分别为98.33%、90.00%,且观察组的痊愈和显效患者显著多于对照组(P<0.05)。见表2。
表2两组患者的临床疗效比较[n(%)]
2.3两组外周血管内皮生一因子外周血管内皮生一因子((VEGF)及辅助性T细胞17VEGF及Th17/Treg比较
治疗前观察组、对照组外周血VEGF及Th17/Tre水平差异无统计学意义(P>0.05),治疗8周后两组外周血VECE及Th17/Tre水平显著降低,观察组显著低于对照组,组间差异有统计学意义(P<0.05)。见表3。
2.4两组DLQI评分比较
治疗前观察组、对照组皮肤病生活质量指数(DLQI)评分差异无统计学意义(P>0.05),治疗后两组DLQI评分均显著降低(P<0.05),但组间差异仍无统计学意义(P>0.05)。见表4。
2.5两组血清细胞因子水平比较
表5两组血清细胞因子水平比较
其中,与治疗前比,P①<0.05,与对照组比,P②<0.05。
3、结论
本研究结果显示,治疗后患者PASI评分、DLQI评分、外周血VECE及Th17/Tre水平均较治疗前显著降低,且治疗后观察组患者PASI评分、DLQI评分、外周血VECE及Th17/Tre水平均显著低于对照组,提示本发明药物与中药热敷联合308nm LED光源照射治疗白癜风在缩小皮损面积、改善皮损状况,更好地维持外周血VECF及Th17/Trer细胞平衡,以及提高患者生活质量方面效果显著。观察组治疗有效率高于对照组,反映出观察组采用的治疗手段更具优势。此外,两组治疗期间均无严重不良反应发生,说明两种治疗方法安全性均较高。
既往研究证实,细胞因子TNF-α、IFN-γ作为促炎症因子参与白癜风的病情进展过程,而IL-10是调节免疫功能的细胞因子,作为促免疫功能因子,血清IL-10水平升高则可提高机体免疫功能,减缓白癜风的病情进展。本研究结果表明,治疗后两组患者血清TNF-α、IFN-γ水平均显著低于治疗前,IL-10水平显著高于治疗前;治疗后观察组患者血清TNF-α、IFN-γ水平均显著低于对照组,IL-10水平显著高于对照组。可见,本发明药物与中药热敷联合308nm LED光源照射治疗白癜风疗效确切,可显著减轻患者白斑皮损,更有利于调节机体免疫功能,抑制炎性损伤,且临床安全性好,并且,相比308nm LED光源照射+中药热敷治疗,联合本发明药物治疗能够发挥中药内服调节机体免疫功能和炎症反应的作用。
以上所述,仅为本发明的具体实施方式,但本发明的保护范围并不局限于此,任何熟悉本技术领域的技术人员在本发明揭露的技术范围内,可轻易想到变化或替换,都应涵盖在本发明的保护范围之内。因此,本发明的保护范围应以所述权利要求的保护范围为准。
Claims (9)
1.一种治疗白癜风的中药组合物,其特征在于,包括以下重量份的原料药:
柴胡3-8重量份、黄芩3-8重量份、法半夏5-15重量份、桂枝5-15重量份、防风5-15重量份、炒白术5-15重量份、黄柏3-8重量份、薏苡仁3-8重量份、牛膝5-15重量份、知母5-15重量份、百合5-15重量份、金钱草5-50重量份、络石藤5-50重量份、白芷5-15重量份、当归5-15重量份、桃仁3-8重量份、黄精5-15重量份、杜仲5-15重量份、阿胶5-15重量份。
2.根据权利要求1所述治疗白癜风的中药组合物,其特征在于,包括以下重量份的原料药:
柴胡5重量份、黄芩5重量份、法半夏10重量份、桂枝10重量份、防风10重量份、炒白术10重量份、黄柏5重量份、薏苡仁5重量份、牛膝10重量份、知母10重量份、百合10重量份、金钱草10重量份、络石藤10重量份、白芷10重量份、当归10重量份、桃仁5重量份、黄精10重量份、杜仲10重量份、阿胶10重量份。
3.权利要求1或2所述治疗白癜风的中药组合物的制备方法,其特征在于,包括如下步骤:取各重量份的原料药,加溶媒提取,经过滤、浓缩、干燥后,即得。
4.根据权利要求3所述治疗白癜风的中药组合物的制备方法,其特征在于,所述溶媒为水或乙醇水溶液。
5.根据权利要求3所述治疗白癜风的中药组合物的制备方法,其特征在于,所述提取为煎煮提取、回流提取、浸渍提取、超声提取中的任意一种。
6.根据权利要求3所述治疗白癜风的中药组合物的制备方法,其特征在于,取各重量份的原料药,加水煎煮提取2次,每次提取的料液比为1:8-12,每次提取的时间为20-30min,经过滤、滤液合并、浓缩、干燥后,即得。
7.一种治疗白癜风的中药制剂,其特征在于,所述治疗白癜风的中药制剂包括权利要求1或2所述治疗白癜风的中药组合物,以及药学上可接受的辅料。
8.根据权利要求7所述治疗白癜风的中药制剂,其特征在于,所述治疗白癜风的中药制剂的剂型为汤剂、散剂、丸剂、胶囊剂、颗粒剂、片剂和口服液中的任意一种。
9.权利要求1-2之一所述治疗白癜风的中药组合物在制备治疗白癜风的药物中的应用。
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